Phase 2
N=25
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Mantle-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00878254 ↗Enrolled (actual)
25
Serious AEs
32.0%
Results posted
Jul 2025
Primary outcome: Primary: Progression-Free Survival (PFS) — 8 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- G-CSF (Biological); Rituximab (Drug); Cyclophosphamide (Drug); Cytarabine (Drug); Doxorubicin (Drug); Etoposide (Drug); Ifosfamide (Drug); Leucovorin (Drug); Mesna (Drug); Methotrexate (Drug); Vincristine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
8 | — |
| PRIMARY Progression-Free Survival (PFS) Rate at 5 Years Using Kaplan-Meier Method |
57.1 | — |
| SECONDARY Overall Survival (OS) Rate at 5 Years Using Kaplan-Meier Method |
79.7 | — |
| SECONDARY Rate of Response to Study Therapy |
20; 0; 2 | — |
| SECONDARY Number of Participants Experiencing Treatment-Related Serious Adverse Events During R-MACLO/IVAM Induction Therapy |
2 | — |
| SECONDARY Number of Participants Experiencing Treatment-Related Adverse Events During R-MACLO/IVAM Induction Therapy |
25; 24 | — |
Summary
The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).
Eligibility Criteria
Inclusion Criteria
- Previously untreated, histologically confirmed mantle cell lymphoma,
- Measurable or evaluable disease (at least one site with >1.5 cm in diameter
- All stages are eligible
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate hepatic function:
- Bilirubin < 3 mg/dL
- Transaminases (serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate-pyruvate transaminase (SGPT)) < than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement
- Serum creatinine< 1.5 mg/dl
- Ability to give informed consent
- Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
- Life expectancy greater than 6 months.
Exclusion Criteria
- Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
- Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
- Grade 3 or 4 cardiac failure and/or ejection fraction < 50.
- Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
- Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
- Presence of hepatitis or hepatitis B virus (HBV) infection.
- Pregnant or breast-feeding women.
- Central Nervous System (CNS) involvement.
Data sourced from ClinicalTrials.gov (NCT00878254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.